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A Multicenter, Controlled Clinical Trial to Evaluate the Hologic Tomosynthesis Mammography

18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

A Multicenter, Controlled Clinical Trial to Evaluate the Hologic Tomosynthesis Mammography

Inclusion Criteria:

- Female

- Any ethnic origin

- No contraindication of routine bilateral mammography

Exclusion Criteria:

- Any contraindications to mammographic screening, including but not limited to:

- Significant existing breast trauma

- Pregnancy

- Lactating

- Previous surgical biopsy

- Previous breast cancer

- Placement of an internal breast marker

- Breast implants

- Unable to understand and execute written informed consent

- Breasts are too large to be imaged on the 24 cm by 29 cm detector with a single

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

To detect a statistically significant increase in the area under the ROC curve when comparing 2-D plus 3-D images to the 2-D images. The ROC curves will be generated from the probability of malignancy scale, a score of 0% to 100%.

Outcome Time Frame:

Fall 2010

Safety Issue:



United States: Institutional Review Board

Study ID:




Start Date:

September 2009

Completion Date:

January 2013

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • breast cancer screening
  • Breast Neoplasms



Mayo Clinic Rochester, Minnesota  55905
Fletcher Allen Health Care Burlington, Vermont  05401
Massachusetts General Hospital Boston, Massachusetts  02114-2617
University of Virginia Charlottesville, Virginia  22908
Elizabeth Wende Breast Clinic Rochester, New York  14620
Albert Einstein Medical Center Philadelphia, Pennsylvania  19141
Spectrum Health Grand Rapids, Michigan  49503
Boca Raton Community Hospital Boca Raton, Florida  33486
University of Cincinnati Cincinnati, Ohio  45267-0502
University Hospitals Case Medical Center Cleveland, Ohio  44106
UC Davis Sacramento, California  95817
HOAG Memorial Hospital Newport Beach, California  92658-6100
Magee Women's Hospital Pittsburgh, Pennsylvania  15213
Scottsdale Medical Imaging Ltd. (SMIL) Scottsdale, Arizona  85251
Invision/Sally Jobe Greenwood Village, Colorado  80111
Memorial Florida Hollywood, Florida  33021
Luthern General - Advocate Health Care Chicago, Illinois  60068
Barnes Jewish St. Louis, Missouri  63110
York - Women's Imaging at Apple Hill York, Pennsylvania  17403
UTSW Center for Breast Care Dallas, Texas  75039
Memorial Hermann/ Memorial City Houston, Texas  77074
Intermountain Medical Imaging Murray, Utah  84175